References
- US FDA . Guidance for industry: bioanalytical method validation (2018). http://www.fda.gov/downloads/drugs/guidances/ucm070107.Pdf
- Piccoli S , Mehta D , Vitaliti A et al. 2019 white paper on recent issues in bioanalysis: FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation (part 3 – recommendations on 2019 fda immunogenicity guidance, gene therapy bioanalytical challenges, strategies for critical reagent management, biomarker assay validation, flow cytometry validation & CLSI H62). Bioanalysis 11(24), 2207–2244 (2019).
- Bustin SA , Benes V , Garson JA et al. The MIQE guidelines: minimum information for publication of quantitative real-time PCR experiments. Clin. Chem. 55(4), 611–622 (2009).